CQV System Lead - Facilities / Utilities / Rooms

Job Title – CQV System Lead - Facilities / Utilities / Rooms

Job Location Devens MA  -Onsite from day one -4x days on site / 1 remote (May go to 3 days once onboarded) -Need to be local OR WHO CAN RELOCATE FROM DAY ONE

Duration - 6 Months+

Visa  - Any Visa except H1B,CPT

Mode Of Interview -  Phone/Skype

Note – Need LinkedIn 

Job description

Lead C&Q deliverables and field coordination for facilities, utilities, HVAC, cleanrooms, process gases, room qualification, and building-system interfaces. This role needs a field-capable facilities/utilities validation lead who can work across construction turnover, walkdowns, commissioning evidence, PSSR, green tag, blue tag, IOQ/PQ where applicable, and final qualification reporting.

Project scope to screen against:

• Relevant utility systems include AHU, clean/process air distribution, oxygen, carbon dioxide, helium, liquid nitrogen, steam, chilled water, process tempered water, process waste, storm waste, security, fire alarm/protection, UPS, manufacturing pass-through boxes, and utility panels.
• Relevant room scope includes MAL/PAL areas, vial storage, viral vector rooms, vial thaw, storage, corridors, and filling suite rooms with room qualification deliverables.
• Direct Impact utilities such as process gases and steam may require IOQ, QSR, blue tag, and PQ; No-Direct Impact utilities still require commissioning, turnover package, PSSR, green tag, commissioning summary, and blue tag.
• Facilities design inputs include architectural general arrangements, HVAC environmental classification plans, differential pressure airflow plans, HEPA filter locations, HVAC airflow diagrams, utility P&IDs, process gas P&IDs, and compendial water schematics as available.
• Support room qualification including airflow visualization, environmental classification, HEPA integrity testing, and recovery studies.
• Coordinate integrated system testing with Automation and Engineering teams.
• Manage deviations, punch lists, and change controls.
• Ensure project documentation is inspection-ready.

Required experience:

• 8-12+ years facility/utilities CQV
• HVAC/cleanrooms, process gases, WFI/clean steam/clean air preferred
• room classification/testing coordination
• construction turnover fluency.

Technical screening criteria:

• 8-12+ years facility/utilities CQV in GMP manufacturing, preferably biologics, sterile, cell/gene therapy, vaccine, or pharmaceutical capital projects.
• Hands-on HVAC/cleanroom qualification experience: AHUs, HEPA filters, pressure cascades, airflow visualization/interface, room classification, environmental monitoring coordination, and cleanroom test vendor management.
• Utilities experience with process gases, clean/plant air, oxygen, carbon dioxide, steam, chilled water, process tempered water, liquid nitrogen, process waste, utility panels, pass-through boxes, and UPS/fire/security interfaces.
• Strong construction turnover package review and field walkdown background; can identify missing evidence before it delays green tag/blue tag or qualification execution.
• Experience with ISPE Baseline Guides, ASTM E2500, and GMP regulations.
• Strong communication, planning, and leadership skills.

Responsibilities:

• Own utility/facility/room C&Q deliverables
• coordinate TOP review, PSSR/Green Tag/Blue Tag evidence, room qualification interfaces, utility stability readiness, and commissioning summary reports.

Project deliverables / ownership:

• Own assigned facility, utility, and room commissioning/qualification deliverables: design review, DQ/QRA/traceability where applicable, commissioning protocol/report, IOQ/PQ as required, QSR, green tag, blue tag, and turnover evidence.
• Coordinate PSSR readiness, TOP review, walkdowns, test vendor scheduling, room qualification interfaces, utility stability readiness, and commissioning summary reports.
• Track discrepancies, punch items, calibration needs, external certification/testing gaps, and field evidence issues through closeout.
• Feed status and blockers into PM/document control trackers and coordinate with process/aseptic system leads when utility or room readiness affects equipment execution.

Tools, field work, and interfaces:

• Must coordinate with construction manager, engineering/design, utilities/facilities, vendors, certifiers/testing firms, operations, quality, and system leads.
• Hybrid role with onsite presence for walkdowns, commissioning, testing, PSSR, and green tag/blue tag readiness in Devens, MA.
• ValGenesis/Forma familiarity preferred for turnover and qualification record management.

Sourcing profile: Search for Facilities Utilities CQV Lead, HVAC Validation Engineer, Cleanroom Qualification Lead, Utilities Validation Engineer, Commissioning Qualification Utilities Lead.